RESUMEN
OBJECTIVE: To observe the clinical efficacy and safety of Simiao Xiaobi Decoction (SXD) in treating active rheumatoid arthritis (RA) of humid pyretic toxic Bi-Zheng (HPTB) syndrome type. METHODS: One hundred and twenty RA patients were randomly assigned to 2 groups, 60 in the treatment group receiving SXD, and 60 in the control group receiving methotrexate, all were treated for 12 weeks. Clinical efficacy in patients was evaluated, referring to the criteria recommended by European League Against Rheumatoism (EULAR), in terms of effective rate, main symptoms, signs, scoring on symptom/sign by Chinese medicine scale and DAS28, physical and chemical indices, long-term outcome of patients and the average therapeutic effect initiating time. Meantime, the adverse reaction was recorded. RESULTS: The study was completed in 103 patients, 52 in the treated group and 51 in the control group. According to a per-protocol analysis, the effective rate was better in the treatment group than in the control group with marked difference in terms of Chinese and Western medicine respectively (92.3% vs 70.6% and 86.5% vs 62.7%, P<0.05). Superiorities in the treatment group were also seen in the improvements of main symptoms and signs, symptom/sign scores, DAS28 scores, and long-term outcome. Moreover, the average therapeutic effect initiating time was shorter (5.31 +/- 0.36 weeks vs 8.28 +/- 0.45 weeks), while the incidence of adverse reaction was less in the treatment group than in the control group (6.7% vs 43.3%, P<0.05). CONCLUSION: SXD can improve the joint symptoms and general condition of RA patients of HPTB type with shorter initiating time and less adverse reaction.
Asunto(s)
Artritis Reumatoide/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Fitoterapia , Adulto , Antirreumáticos/uso terapéutico , Femenino , Humanos , Masculino , Metotrexato/uso terapéutico , Persona de Mediana EdadRESUMEN
OBJECTIVE: To observe the clinical efficacy on analgesia and detumescence of Cheezheng Qingpeng ointment in the treatment of rheumatoid arthritis. METHODS: From December 2004 to May 2006, 78 patients were divided into the treatment group and the control group randomly using PROC PLAN from SAS software. There were 40 patients in the treatment group, 30 patients were male and 10 patients were female, with an average age of (48.2+/-9.7) years, who were treated with Cheezheng Qingpeng ointment external treatment. Thirty-eight patients were in the control group, 30 patients were male and 8 patients were female, with an average age of (47.7+/-13.7) years, and were treated with Diclofenac diethylamine emugel. All the patients were treated for 2 weeks. The metacarpophalangeal joint with most severe pain and swelling was observed. The indexes including joint pain, tenderness, swelling, joint motion and morning stiffness were detected and the VAS scores were compared between the two groups. RESULTS: All the patients completed the trial, 35 patients in the treatment group and 33 patients in the control group. At the end of 2 weeks, 1 patient in the treatment group obtained an excellent result, 27 good and 7 bad; in the control group, 2 patients got an excellent result, 20 good and 11 bad. There were no statistically difference of therapeutic effects between the two groups. At the 1st week after treatment, the joint swelling score of the treatment group was (4.0+/-1.4), which was lower than the (5.5+/-1.9) in the control group. CONCLUSION: There is no obvious difference of therapeutic effects between Cheezheng Qingpeng ointment and diclofenac diethylamine emugel for the treatment of rheumatoid arthritis, but the relieving of swelling of Cheezheng Qingpeng ointment is better than that of Diclofenac Diethylamine Emugel.